Entries from HEALTH LAW SECTION BLOG tagged with 'AERs'

Drug regulation and investments in it-the Matrixx case

The ‘Questions’ presented in the Supreme Court case Matrixx Initiatives, Inc. et al petitioners v. James Siracusano, et al (No. 09-1156) vary among the documents filed in the case, illustrating the complexity of 21st century drug regulation and investments in...

FDA's Safe Medication Use Initiative

Read about the launching of FDA’s Safe Use Initiative and the dedicated webpage.(1) The Agenda and transcripts of the respective presentations and discussion from the Nov 16-17 CDER public workshop spotlights some of the opportunities in certain drugs, drug classes...

The FDA Postmarketing Drug Safety Information website

From the FDA news (1):On June 15, 2010, FDA began posting summaries of Agency safety analyses of recently approved drug and biologic products. These summaries are intended to share what the FDA has learned about the safety of products 18...

AERS: a useful tool for FDA

Excerpts from (FDA) CDER news 4/6/09. AERS, the Adverse Event Reporting System,contains over 4 million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented here (1) as summary statistics covering data received...

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